Proceedings of the 6th National Patient Reported Outcome Measures (PROMs) Annual UK Research Virtual Conference, Bridgend, Wales 2022

Background: Children and young people (CYP) with life-limiting or life-threatening conditions (LLLTC) face speciﬁc challenges when self-reporting health outcomes, including communication difﬁculties and sensitivities around subject matter. No ideal self-reported patient-centred outcome measure (PCOM) currently exists for this population. Practical aspects of design need to be considered in line with CYP’s preferences and capabilities to ensure meaningful participation in measurement, and to enable child-and family-centred care. Aims: To identify preferences for PCOM response format, recall period, administration mode, and length, among CYP with LLLTC. Methods: Semi-structured qualitative interviews with CYP aged 5–17 years with LLLTC. CYP were purposively sampled from nine UK sites. Verbatim transcripts were analysed in NVivo using Framework analysis with inductive and deductive coding. Results: 26 CYP with a range of LLLTC (primary diagnosis: 10 gastrointestinal, 6 cancer, 5 neurological, 3 congenital, 1 metabolic, 1 respiratory) were inter-viewed. Response format: many participants reported familiarity with numeric response scales, especially for pain. However, most preferred response formats with pictures, most often emojis. Children under 10 years old in particular preferred emojis, while preferences among older CYP were more variable. Recall period: Participants preferred a short recall, either because they cannot remember far back, or they do not want to think about past ill health. Most felt that they could report health-related outcomes from between the past day up to the past week. Older CYP tended to favour longer recall periods compared to younger children. Administration mode: whilst most participants preferred to complete measures electronically or had no preference, a small number had a strong preference for paper-based measures, suggesting PCOMs should be available in multiple formats. Length: ten or fewer questions were preferred. Conclusions: CYP with LLLTC interviewed are accustomed to answering questions about their own health and can communicate preferences to inform PCOM design. Generally, they prefer visually appealing response formats, short measures, and electronic administration. Importantly, respondent burden needs to be considered at the design stage, as demonstrated by preferences for a brief measure and short recall period. The results presented have practical implications for design and development of PCOMs for CYP with LLLTC, whose voices

Cardiff and Vale and Cwm Taf Morgannwg University Health Boards introduced Long COVID Rehabilitation Services to support people with Long COVID between December 2020 and January 2021 as a response to the Covid-19 pandemic and the emergence of patients with symptoms following COVID-19 infection. The multi-disciplinary teams include physiotherapists, occupational therapists, speech and language therapists, dieticians, and for some teams, psychologists and GPs. The services provide an initial one-to-one assessment which may be followed by further individual interventions, and in some cases group interventions. These aim to provide self-management advice and techniques for rehabilitation. The services were initially funded by individual health boards, but subsequently received additional funding from the Welsh Government as part of the 'Adferiad' (Recovery) programme. Cedar Health Technology Research Centre carried out a Social Return on Investment (SROI) for both of these health boards, linked to Cedar's work at national level together with Welsh Value in Health Centre (WViHC) and all Local Health Boards. Social Return on Investment (SROI) is a method of evaluating the impact of a service, by measuring changes that are relevant to the people or organisations that experience or contribute to the service. This is used to understand where the value lies, who experiences that value and its importance to them, as well as calculating a ratio of benefits to costs. Cedar used the nationally collected patient-reported outcome and experience measures (PROMs and PREMs), together with interviews, SROI specific surveys and group discussions to gather views from stakeholders, primarily service users, but also their families, service providers, GPs and an employer. The key outcomes reported by service users were the feeling of being listened to, understood and believed, and meeting (virtually) other people who were going through similar experiences. ''somebody listening and understanding, believing in you. Being referred to the hub gave my condition legitimacy-taken seriously.'' ''all of a sudden it's like-I'm not making this up, there are actually other people who feel the same as me.'' For some people the impact of these was a turning point in how they felt they were coping. People mentioned learning to pace themselves and not try to ''push through'', and how information such as an occupational therapist's plan for return to work could help them cope. ''me telling them I need a really slow phase to return isn't the same as somebody in a healthcare position telling them.'' A3 The Clinical Meaning of Family Reported Outcome Measure (FROM-16) Scores: Translational Research to Support Holistic Clinical Practice A4 Patient-centred outcome measure design: the perspectives and preferences of children and young people with life-limiting or life-threatening conditions Background: Children and young people (CYP) with life-limiting or life-threatening conditions (LLLTC) face specific challenges when self-reporting health outcomes, including communication difficulties and sensitivities around subject matter. No ideal self-reported patientcentred outcome measure (PCOM) currently exists for this population. Practical aspects of design need to be considered in line with CYP's preferences and capabilities to ensure meaningful participation in measurement, and to enable child-and family-centred care. Aims: To identify preferences for PCOM response format, recall period, administration mode, and length, among CYP with LLLTC. Methods: Semi-structured qualitative interviews with CYP aged 5-17 years with LLLTC. CYP were purposively sampled from nine UK sites. Verbatim transcripts were analysed in NVivo using Framework analysis with inductive and deductive coding. Results: 26 CYP with a range of LLLTC (primary diagnosis: 10 gastrointestinal, 6 cancer, 5 neurological, 3 congenital, 1 metabolic, 1 respiratory) were interviewed. Response format: many participants reported familiarity with numeric response scales, especially for pain. However, most preferred response formats with pictures, most often emojis. Children under 10 years old in particular preferred emojis, while preferences among older CYP were more variable. Recall period: Participants preferred a short recall, either because they cannot remember far back, or they do not want to think about past ill health. Most felt that they could report health-related outcomes from between the past day up to the past week. Older CYP tended to favour longer recall periods compared to younger children. Administration mode: whilst most participants preferred to complete measures electronically or had no preference, a small number had a strong preference for paper-based measures, suggesting PCOMs should be available in multiple formats. Length: ten or fewer questions were preferred. Conclusions: CYP with LLLTC interviewed are accustomed to answering questions about their own health and can communicate preferences to inform PCOM design. Generally, they prefer visually appealing response formats, short measures, and electronic administration. Importantly, respondent burden needs to be considered at the design stage, as demonstrated by preferences for a brief measure and short recall period. The results presented have practical implications for design and development of PCOMs for CYP with LLLTC, whose voices must be included early in measure development to ensure acceptability, feasibility, and enhance valid and reliable self-report. Funding Introduction: This project aimed to investigate the feasibility of using the MYCaWÒ tool (Measure Yourself Concerns and Wellbeing) within a NHS frailty service, to provide greater insight into the specific needs of people living with mild, moderate and severe frailty (as defined by the Rockwood Clinical Scale-RCFS). MYCaWÒ is a short tool, which is routinely incorporated into consultations to understand and prioritise needs and concerns. The tool enables the individual to assign a score to the problem/concern and their wellbeing. Follow-up enables measurement of changes in reported concerns and wellbeing over time. Method: Participants were recruited either through use of Complex Care at Home Service (CC@H) provided by Gloucestershire Health and Care Foundation Trust, or South Cotswolds Frailty Service (SCFS), an anticipatory care community service delivered by the South Cotswolds Primary Care Network (PCN). RCFS and MYCaWÒ data were collected by service staff. Data was also collected from healthcare practitioners about their experience of using MYCaWÒ. Results: 310 people (257 from CC@H and 53 from SCFS) completed the baseline questionnaire and 113 people provided follow-up MYCaWÒ concern and wellbeing scores data. The modal person was 85-89 years old and female. Despite experiencing severe frailty, patients' designated MYCaWÒ concerns scores showed statistically significant improvements, and a high percentage of people (71%) had clinically significant levels of score changes. There was a statistically significant mean improvement in wellbeing scores. When that data was stratified and analysed according to RCFS severity, concerns improved regardless of level of severity of frailty, but wellbeing only statistically improved for people experiencing mild frailty. RCFS scores did not change over time. Conclusion: A bespoke MYCaWÒ frailty coding framework was created by revising the existing coding framework for MYCaWÒ. This framework provides a standardised yet rich picture of the concerns that are important to patients experiencing frailty. The five most frequent concerns related to mobility, managing the household and activities of daily living (ADLs), physical problems, housing and independence. The top concerns for mild and moderate frailty were physical (mobility) and the top concern for severe frailty was ADL. Importantly, this information can be used by healthcare practitioners to improve the personalised nature of the support they provide. The MYCaWÒ tool was implemented in the services' systems and data was successfully collected from a fragile cohort during the Covid-19 pandemic. Staff experience of using MYCaWÒ showed that the measure was acceptable and worked well in practice. Health in Wales states 1 that 'it is patients themselves who are best placed to judge how they feel'. We therefore need ways to ask them to 'assess how they feel, from their own perspective' against a standardised outcome framework. This presentation will report on a research and development project to address this need, funded by Welsh Government through the Small Business Research Initiative (SBRI) and led by Here2there.me Ltd (H2t). It offers a novel way to blend the setting and recording of personal goals with the use of standardised outcomes frameworks. H2t has developed a personcentred planning and outcomes recording tool called 'ForMi'. This recognises that outcomes are part of a larger cycle that starts with a person-centred plan. The individual (a patient in this case) has as much ownership of the plan as possible. The tool has been piloted within 9 sites across Wales. The individual (with support) agrees a strength-based profile, a set of goals (in their own words) and a Circle of Support. The Circle could include people from social services, health, education, friends and family: whoever is best placed to help them achieve the goals most important TO them, as well as for them, and record these as outcomes. The agreed goals can be tagged against any standardised outcomes framework. This allows for a fully individualised approach to outcome setting, whilst still enabling standardised PROMS reporting. The goals are 'rated' by the person and a key worker on a 0-10 scale (as recommended by Welsh Government 2 ) at the beginning and end of the intervention or treatment. Depending on the length of the intervention, there may also be intermediate ratings of progress. The system is managed online via a Control Panel. Users are also able to use an App to record their 'story' of achievement against their goals. This unique functionality is similar to many social media platforms, allowing the individual and their Circle of Support to view and upload comments and pictures to support their progress against their goals. This facilitates joined-up working by multi-disciplinary teams and provides crucial evidence to support achievement against outcomes, beyond the subjective opinions of individuals and professionals. We will present experience from pilot projects where the system has been used and will consider other settings where its use could be studied. Bipolar disorder (BD) is a common mental health disorder which affects approximately 2% of the population and is associated with significant morbidity and mortality. It is characterised by episodes of depression and hypomania/mania which vary in severity both between and among individuals. These mood episodes can cause significant problems in everyday life including relationships and work, and many people with BD report ongoing symptoms outside of mood episodes. In recent years there has been an emergence of an increasing number of electronic mood monitoring tools designed for individuals with BD in both clinical and research settings. These tools have predominately employed predefined symptom-based questions to monitor mood at varying time intervals usually ranging from multiple times a day to weekly. We have introduced the True Colours weekly electronic mood monitoring tool into our large-scale UK-wide BDRN research programme. The BDRN True Colours system sends participants weekly email prompts to complete two online self-report questionnaires which measure presence and severity of depressive and hypomanic/manic symptoms over the preceding week. The tool also allows participants to view their longitudinal symptom scores graphically outside of the clinical environment. To date over 1200 BDRN participants have joined True Colours, and of those who have had the opportunity, 50% have engaged for at least 52 weeks with \ 10% engaging for less than one month. Reported patient benefits include tracking moods, spotting trends and triggers, communicating experiences to others, and aiding self-management. Early participants reported that the mood questionnaires alone were not capturing fully their experiences of living with BD. In response to this feedback we added the option for participants to create their own personalised questions to monitor, for example, sleep, physical activity levels, physical health, and mood instability. Thematic analysis of the content of these questions revealed many aspects of BD important to patients in relation to longitudinal monitoring that extended well beyond mood symptoms. Our findings highlight the importance of individualised measures in helping to capture the natural trajectory of BD from the patient perspective. Additional symptoms and aspects of life than those useful diagnostically for BD may be more important for individuals themselves to monitor and have more meaning in capturing their own experience of BD. Future research into the relationships between longitudinally measured patient priority aspects of BD, mood symptoms and long-term outcomes are warranted. These findings may aid the development of clinically effective real-time online personalised self-management tools. included 268 individual RA DA items extracted from the 10 PROMs identified by the systematic review, another PROM not included in the systematic review, a foot-specific PROM, two flare PROMs and a non-measurement group of items. Further items suggested by patients and PPI were also incorporated, including a Pain Activity Scale, discomfort when walking, when standing, and when exercising, plus fear of falling when walking. Demographics were collected, and respondents were given the option to be invited to take part in cognitive interviews and a dissemination event. We collected a dataset of n = 677 in order to develop the item pool. Psychometric properties of all PROMs will be assessed by Rasch measurement theory analyses, which provides results on targeting and item locations, fit to the Rasch model, reliability, local dependency, uni-dimensionality and item threshold ordering. Further analyses will include Mann-Whitney U tests and area under the receiver operating characteristic curve to evaluate if the PROM is able to discriminate between flare and nonflare populations, Spearman's q, Cronbach's a and confirmatory factor analyses (V2 test of fit, RMSEA, CFI, TLI, SRMR). We will go through an iterative process taking items from various PROMs to create an item pool that can be shown to satisfy all necessary aspects. Additionally, a purposive sample of respondents will take part in cognitive interviews to assess validity of items in terms of content and response processes. A CAT will be built on the locations of items in the item pool. This would personalise the PROM and optimise its potential for use in routine clinical practice.
A14 Developing a roadmap towards national collection of electronic patient-reported outcomes for people with chronic kidney disease in the UK Aim: Develop a roadmap for the next 10 years that describes how to establish a national system for collecting electronic patient-reported outcomes (ePROs) for people with kidney disease in the UK. Ultimately, this will enable people with kidney disease to be more involved in their own care and improve their outcomes. Methods: We explored views of key stakeholders on what was needed for establishing a national ePRO system for kidney care in the UK. Key stakeholder groups included kidney patients, healthcare professionals, commissioners, and facilitating organisations (e.g., national audit and service improvement organisations, industry partners, academia). We conducted semi-structured interviews with 18 stakeholder representatives to elicit their perspectives on the topic. In addition, we organised five parallel focus groups as part an online stakeholder event with a total of 58 participants. Focus group topics included: measurement instrument, technology and infrastructure, implementation, ePRO-generated inequalities, and multimorbidity. The research team analysed and synthesised all data thematically. With input from stakeholder representatives, they translated themes into recommendations for how to achieve national collection of ePROs in kidney disease. Results & conclusions: Preliminary analyses from the semi-structured interviews and focus group discussions suggested that not all stakeholders were aware of or had shared views on the potential benefits of ePROs. They indicated that national ePRO collection required support from local healthcare professionals at all organisational levels, while ensuring that solutions for data collection could be adapted to local contexts and patient groups. Stakeholders also suggested that -in addition to evidence of clinical effectiveness-examples of the usability and feasibility of data collection would support the case for a national ePRO system. Lastly, they recommended harnessing existing regional renal service improvement networks as a suitable infrastructure for scaling up ePRO collection, and developing national guidance to guide this wider roll-out. We are currently undertaking the final step, where we present the preliminary findings to the stakeholder representatives as a starting point for codeveloping a set of key recommendations for how to achieve national collection of ePROs in kidney disease in the next 10 years. Patient-reported outcomes (PROs) are collected in clinical trials to provide valuable evidence on the risks and benefits of treatment and in routine clinical practice to support patient-centered care. To increase the positive impact of PRO data and to avoid the unintended consequence of increasing health disparities, we need to consider the needs of under-served groups and identify approaches to ensure greater equality, diversity and inclusion (EDI). To propose actions to promote representation of under-served groups in the collection of PRO data. A rapid literature review to identify and summarise key publications and consultation with international stakeholders (n = 20) and patient partners (n = 2) to 1) identify barriers to EDI and 2) formulate key actions to promote representation of under-served groups in the collection of PRO data. Several challenges to EDI were identified. These included a lack of valid and reliable PRO measures that have been co-developed with, or are relevant to, the target population. PRO measures developed with limited patient input risk omission of key concepts of importance to under-served groups. This is particularly true if these groups are excluded from concept elicitation due to communication barriers arising from learning disabilities, low literacy, or digital exclusion. Failure by trialists and clinicians to use translated and culturally validated PROs threatens to increase racial and ethnic disparities through exclusion of minority ethnic groups from PRO reporting. Lack of culturally appropriate and linguistically validated measures limits the use of PROs within lowand middle-income countries. To promote the representation and participation of under-served population in PROs several actions were proposed: 1) widen participation by ensuring individuals involved in PRO co-development are representative of the target population; 2) be mindful of the clinical characteristics of the disease when designing or selecting a PRO to minimise barriers to completion; 3) acknowledge cultural values through the use of translations; 4) providing accommodations to ensure individuals are able to complete a PRO regardless of ability to read, write and problem solve; 5) consider ways to promote digital inclusion; and 6) engage regulators in EDI discussions early in the drug development life cycle. PRO data needs to reflect the diversity of modern society. Implementation of specific actions to address EDI, both in trials and routine care, can promote representation of under-served groups, reduce health disparities, and result in the collection of meaningful PRO data for the benefit of all. The assessment and treatment of substance-related and addictive disorders can benefit from a holistic consideration of an individual's quality of life (QoL), however, there remains uncertainty over how the construct is operationalised as an outcome measure. The current systematic review aimed to identify all the QoL and health-related quality of life (HRQoL) instruments adopted as outcome measures in addiction research and map the conceptualised domains. Available psychometric evidence supporting their use was also summarised. A systematic search of three electronic databases and a specialised assessment library was conducted for studies utilising a QoL or HRQoL instrument as an outcome measure. Participants using or taking part at risky levels and above assessed with a valid measure were included. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance was followed and included outcome instruments were appraised using mixed-methods. Validation studies were assessed for their risk of bias based on the Consensusbased Standards for the selection of health Measurement Instruments (COSMIN) risk of bias tool. Two hundred and thirty articles containing 258 discrete studies were included. Forty-seven outcome instruments were used: 28 assessing QoL in 141 studies; 19 assessing HRQoL in 117 studies. The WHOQOL-BREF was the most popular instrument utilised in 73 studies. Content analysis identified 39 unique domains of QoL. Eighteen articles comprising 20 validation studies evaluated the psychometric properties of 11 outcome measures. No instrument was assessed for the same parameter in 5 or more studies for meta-analytic pooling purposes. The ALQoLS, ALQoL-9, Q-LES-Q-SF, SF-36, and WHOQoL-BREF all produced multiple, promising internal consistency statistics (Cronbach's a = 0.75-0.97), but with varying degrees of methodological quality. Other parameters of reliability and validity are also reported. It is clear many QoL and HRQoL instruments have been utilised in the field. However, a significant portion of studies applied a small number of popular instruments for which there is minimal high-quality validation evidence provided to support their use with populations at risk of addiction. There is a need for more rigorous primary studies with validation evidence presented for the appropriateness of the QoL or HRQoL assessment instrument chosen. Thematic synthesis was undertaken on 9 included studies and 8 domains were identified as important to patients: Pain, Identity, Income, Daily lifestyle and functioning, Emotional well-being, Support, Ability to adapt and adjust, Ability to move forwards. These findings led to the development of a preliminary conceptual framework Step B: Qualitative study: Interviews with 32 patients and 22 orthopaedic staff (surgeons, methodologists and patient contributors) were undertaken between November 2020 and June 2021 in England. The 8 domains from the preliminary conceptual framework were used as a framework around which to code the interviews. These findings led to the refinement of the conceptual framework.
Step C: Interdisciplinary meetings: The research team ran three meetings with members of the advisory panel: orthopaedic surgeons, methodologists and PPIE members and further refined the conceptual framework. Six domains important to patients were included in the final conceptual framework: Pain, Perception of self, Work and finances, Daily lifestyle and functioning, Emotional well-being and Support. The first five relate to important outcomes for patients. These domains are all inter-related and their importance to patients changed as they recovered. The final domain-Support (from the hospital, physiotherapists and family/friends and feeling informed about the next steps in their recovery)-was vital to patients and lessened the negative impact of the other domains on their quality of life. This research has identified 6 areas that are important to patients during or after a lower limb reconstruction. The next step in this research is to ascertain whether current PROMs used with this group of patients adequately capture these areas of importance.  (2), number of co-morbidities (3) and pre-surgery EQ-VAS (4). KPI 1 showed that schemes 2, 3 and 4 treated those with greater need first. KPIs 2 and 3 showed that while scheme 1 slightly improved overall pre-surgery burden, under a tenth of patients actually benefitted. Schemes 2, 3 and 4 yielded higher overall burden, but the majority of patients benefitted, suggesting significantly hindered outlying patients. This work shows that condition-specific PROM scores can be used as a convenient and sensitive single indicator of patient need to evaluate prioritisation schemes against prudent healthcare principles. An essential component of healthcare professional (HCP) practice is the collection of clinically relevant information from patients to better understand and address their health concerns. This is commonly referred to as the gathering of subjective and objective information. A more recent practice has been the addition of patient-reported outcome and experience measures (PROMs/PREMs, respectively).
Although the use of these tools in practice are becoming more prevalent, often pre-registration curricula for healthcare professionals does not include relevant education regarding PROMs and PREMs. The aim of this knowledge-translation presentation is to provide the knowledge, tools, and resources to design curricular, theory/content and learning activities for PROM/PREMs education at undergraduate level. This presentation is based on a newly created resource guide that focusses on the needs of HCPs and factors that influence PROM/ PREM adoption in practice. Using a mixed method design, this guide is based on (a) evidence from a systematic review, qualitative HCP interviews, and stakeholder consensus-building, and (b) implementation science frameworks. We discuss the development and delivery of effective PROM/PREMs education in pre-registration curricula with a focus on knowledge development and skill acquisition to inform HCPs clinical reasoning, judgement, and subsequent course of action. Using backward design for educational experiences, exemplars from registered nurse and physiotherapy pre-registration programs are included. In summary, the implementation of PROM / PREMs into practice requires careful consideration of ways to integrate these tools into curricula. Embedding PROM/PREMs into pre-registration education could facilitate their inclusion in the routine practice of postregistration, novice clinicians. Facilitating HCP adoption of PROM/ PREMs to include patients' voice in their care is a complex behaviour change that can start by preparing the next generation of HCP. Using the proposed, resource guide can facilitate this process to address the needs of HCPs and specific barriers to PROM/PREM implementation.
A24 The Association of Baseline Score and Minimal Clinically Important Difference in Hip Replacements -An Exploration Using Item Response Theory and Interval Scale Methods may be associated with the baseline score. This study aims to assess the impact of baseline score on MCID, and explores whether a score derived at a trait level using item response theory improves the accuracy of the MCID estimation. Methods: The MCID of the Oxford Hip Score was derived from data on 149,055 patients who received a primary hip replacement. The anchor 'a little better' at 6-months on the global change score defined minimal improvement. The MCID was calculated for the whole cohort and baseline score subgroups using interval scale and IRT derived scores. The sensitivity (sens), specificity (spec), area under the curve (AUC) of the receiver operating characteristic curve, positive (ppv) and negative (npv) predictive value and Odds ratio (OR) were calculated using the global change score as the gold standard. Results: The MCID for the without baseline calibration was 12.69 (interval scale) and 1.39 (IRT scale).
With baseline calibration, the MCID ranged from 3.51 -17.29 (interval scale) and 0.56 -2.14 (IRT scale). The sens, spec, ppv and npv were similar for the MCID derived from interval and IRT scales. However, if the MCID was defined as a function of baseline score, the sens, spec, ppv and npv were consistently higher. For the interval scale, ROC AUC was 0.6 (95%CI 0. Objectives: To explore the convergent validity of EQ-5D (total score and dimensions) with core outcomes in dementia by systematically reviewing the literature to understand these empirical relationships, and how they may be impacted by EQ-5D rater-type. Methods: To identify articles relevant to the convergent validity of both the threelevel and five-level versions of EQ-5D with core dementia outcomes, three electronic databases were searched in April 2021. Pre-defined exclusion and inclusion criteria were applied upon screening of the records. A purposefully developed data extraction form was used to capture the relevant data, and a narrative synthesis was adopted. Results: The search strategy retrieved 236 unique records, of which 29 met the inclusion criteria for the review. Twelve different core outcome instruments were used to capture the dementia outcomes: cognition, function, and behaviour/mood across the studies, of which the MMSE was the most dominant tool. The majority of the studies used EQ-5D-3L (n = 24). EQ-5D had a clearer, stronger relationship with the measures of function and behaviour/mood, showing little evidence of association with cognition. EQ-5D dimensions exhibited associations with the appropriate corresponding clinical outcomes, for which the relationships were stronger with proxy-EQ-5D than for self-rated EQ-5D. Conclusion: Measuring health-rated quality of life (HRQoL) in dementia populations is a complex issue, particularly when considering balancing the challenges associated with both self and proxy rating. While EQ-5D-3L shows good convergent validity with dementia outcome measures and captures the key symptoms relevant to dementia HRQoL, there is a need for more evidence on EQ-5D-5L. Future research should focus on how to address the little evidence of association of EQ-5D with cognition.
A26 The need for Nurse Researchers and how their research can be instrumental in embedding a positive research culture into practice City of Wolverhampton delivered this program from 6 main sites and WV Active at Aldersley stadium was the largest site. We undertook a service user evaluation of this site to assess its effectiveness as a mass vaccination site. Methods: Engaging a group of people including staff members of the vaccination site, as well as service users, we developed 2 mixed questions proformas to use for this evaluation. One was used for people aged between 12 and 17 years (Group 1) and the other was used for people aged 18 years and above (Group 2). Each proforma was given to 100 consecutive users from group 1 and 150 consecutive users from group 2. User's responses were recorded in MS Excel 2010 for analysis. Results: Group 1: Of 61 responses, 93% were aged between 12-15 years, 51% females, 70% White, 10% Asians and 3% Black. 59% were having their first vaccine dose. Rise in infection (56%) followed by travel (16%) were two top reasons for getting a jab. Users felt confident (9 ± 1(Median ± SD)), were happy with the information provided to them (9 ± 1.3), felt safe (98%) and rated their overall experience as positive (10 ± 0.9) with high recommendation rates (95%). Introduction: In Belgium, we have a variety of specialised outpatient and residential Alcohol and Other Drugs (AOD) services, but little is known about their effectiveness and efficiency as research on outcomes of these services is limited. Patient-Reported Outcome Measures (PROMs) and Patient-Reported Experience Measures (PREMs) provide excellent tools and a framework to monitor progress and outcomes based on experiences of service users. Objectives: The OMER-BE project aims to: (1) Assess and compare patient characteristics at baseline in various treatment modalities; (2) Test and prepare the routine measurement and monitoring of PROMs and PREMs in AOD services in Belgium using a self-report tool; (3) Assess patient-reported experiences qualitatively in various treatment modalities for AOD patients in Belgium. The overall goal is to continuously assess and improve AOD services in Belgium. Methods: We will set up a naturalistic, longitudinal cohort study for which we will engage and follow up 250 AOD users as they present themselves in selected AOD services in five different treatment modalities (outpatient non-pharmacological treatment, outpatient substitution treatment, residential psychiatric treatment, therapeutic communities for addictions and mobile outreach teams). Sociodemographic, clinical, and intervention factors and PROMs will be assessed at baseline. PROMs and PREMs will be assessed at 45-, 90-and 180-days followup. The questionnaires that will be used during the baseline and follow-up assessments are based on the ICHOM Standard Set for Addictions (ICHOM SSA) (2020), a set of brief validated questionnaires to measure and monitor treatment outcomes routinely in AOD services. Following the 6-month follow-up we will perform a qualitative study in a subset of N = 25 participants (5 per treatment modality). These participants will be invited to take part in an indepth interview with one of the researchers, where the following topics will be discussed: treatment history, recovery experiences, helping and hindering factors in recovery, and experiences with different treatment modalities. The paper explores the impact of the COVID-19 pandemic on patients' experiences of general practice in England using multicategory response data from the 2020 and 2021 GP Patient Surveys, where the former was conducted in the run up to the first UK national lockdown at the end of March 2020 and the latter a year later. It offers a novel analysis of changes in patients' experience that is sensitive to changes in the distribution of patients across the full set of response categories, not just in the proportion meeting some binary quality threshold. The change in GP service quality nationally is measured as the difference in the chances that the overall experience of a randomly chosen patient in 2021 was better rather than worse than that of a similarly chosen patient in 2020. We similarly measure quality change at the individual practice level and break this down into a part attributable to the change in the national patient experience profile and a residual due to idiosyncratic practice-level profile changes, mirroring the distinction between structural and exchange components in the social mobility literature. Patients' overall experience of their GP practice is shown to have improved with a 4.47 percentage point higher chance that a randomly chosen patient from anywhere in England in 2021 would have reported a better rather than worse overall experience of their GP practice than one similarly chosen in 2020. Practice-level changes exhibit reversion towards the median quality for England as a whole, likely reflecting the influence of transitory shocks to patient experience at patient and practice level, with the average change in patients' rating of their own practice found to be slightly higher than the nationwide improvement due to the pattern of exchange mobility. Patients in 2021 were likely to rate their GP practice more highly if their last appointment was conducted faceto-face at their own practice rather than remotely over the phone or online. We conclude that patients' more positive rating of their GP practice in 2021 was not a reaction to the prescribed switch towards the greater use of remote consultations, thereby contributing to the current debate on whether this change should be reversed once the pandemic is over. We conjecture instead that it was the result of a change in reporting behaviour stemming from a more supportive attitude towards the NHS during the pandemic. Their accuracy was evaluated using the area under the receiver operating characteristic curve (AUROC) discrimination metric. Results: The classifier with the best discrimination performance at training was extreme gradient boosting. The most important predictor for EQ-VAS improvement was a patient's preoperative EQ-VAS. For total OHS and total OKS improvement the most important predictors were the pre-operative condition-specific PROM's total score (total OHS or total OKS), the OHS or OKS limping dimension and the surgery revision status. The AUROC metric was higher when the models were tested on English data rather than on CAV UHB data. It was also higher for the models predicting post-operative EQ-VAS improvement in comparison to those predicting total OHS or total OKS improvement. Conclusions: Supervised learning classifiers were successfully developed using English records to predict improvement in post-operative PROM scores. Predicting improvement of EQ-VAS was easier (i.e. higher AUROC scores) than predicting total OHS or total OKS improvement. The predictive performance of the models when tested on CAV UHB data was worse than when they were tested on English data. These results suggest the need to develop predictive models directly on CAV UHB data to improve predictions in the CAV UHB cohort.
A35 National evaluation of the 'Adferiad' (Recovery) Programme supporting the Welsh Long COVID Service 'Long COVID' refers to a wide range of signs and symptoms that persist or develop after acute COVID-19 illness caused by SARS-CoV-2 viral infection. It is not only associated with significant health and socio-economic harm for the affected individuals, but it also leads to an increase on NHS workload. In June 2021, the Welsh Minister for Health & Social Services announced the launch of the 'Adferiad' (Recovery) programme, funding the seven Welsh Local Health Boards (LHBs) to introduce a new suite of patient pathways combined with new/expanded primary and community rehabilitation services to support people with Long COVID. Welsh Government decided to review the programme every 6 months to monitor and assess the efficacy of the new services provided. Cedar Health Technology Research Centre and the Welsh Value in Health Centre (WViHC) supported the LHBs in responding to this request by facilitating data collection via a national survey, and by providing data analysis, reporting and summary at a national level. The data collected included patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs). A survey was administered via the internet to Long COVID service users from all LHBs and anonymised responses were collected by Cedar. The survey included 24 questions investigating service users' demographics, their COVID-19 symptoms, the number of encounters they had with primary care, secondary care and rehabilitation services because of COVID-19, a measure of their generic quality of life (using the EQ-5D-5L PROM questionnaire) and their feedback on the Long COVID service (using a PREM questionnaire). Service users were divided into four groups, depending at which stage they were within the service (i.e. existing service users, new referrals, follow-up and discharged). Summary statistics were extracted from the quantitative data and statistical tests were carried out to identify any significant difference across the four groups in their PROM scores. PREM answers included free text data which was analysed via an inductive qualitative approach. This poster discusses the national evaluation report released by Cedar this year providing feedback on the service.

A36 Development of an Inflammatory Bowel Disease (IBD) Patient-Reported Experience Measure (PREM):
A patient-led consensus work and 'think aloud' study for a quality improvement programme PROM was selected for collection in a consecutive population of men with prostate cancer who had been referred for radiotherapy treatment. The men were approached in the clinical setting with a baseline PROM questionnaire prior to their end of treatment, and then were provided follow-up EPIC-26 PROMs for completion at 6 timepoints up to 2 years after end of treatment. Patients were given the option to complete the PROMs either on paper or electronically, with those opting for electronic emailed the follow-up questionnaires from a bespoke REDCap platform. All PROM data was entered onto the REDCap platform for ease of monitoring and analysis, and the project was conducted under local service evaluation. Results: In total, 20 prostate cancer patients were recruited and completed the baseline EPIC-26 PROM. Of the 20 men, 16 agreed to complete their followup PROMs electronically and 4 opted for pen and paper follow-up. As of 09/03/2022, 16 men had received their 6-week follow-up PROM and 11 had completed (68.75% compliance). Key barriers identified for successful implementation included availability of staffing resource, as this pilot relied on radiographers monitoring follow-ups whilst completing their usual clinical duties. Additionally, information technology was identified as a key barrier, as the REDCap platform formed an additional system for clinicians to access during their clinical consultations. Finally, the scoring system of the PROMs was also identified as a barrier, as there currently exists no consensus on threshold scores requiring further clinical management for patients with side effects as measured by the EPIC-26. Discussion: Overall, various barriers and facilitators have been identified and will be actioned as part of a wider implementation strategy at this Centre. A qualitative study, interviewing key stakeholders and patients involved in the pilot, is already on-going and will provide further critical data for this purpose. . Individual clinical audit is accessed via an online portal and anonymised data from the registry will be published in an annual report. Development of this registry has highlighted many similarities between registries and outcome assessment in human and veterinary patients. There is much we hope to learn from our human counterparts about engagement of both surgeons and owners, as well as data quality, analysis, and reporting. Likewise, as our project develops, we hope through ongoing collaboration, aspects of our experience may be mutually beneficial. A key part of the recruitment process for patient-and caregiverreported studies is verifying eligibility of the prospective participant, referred to as diagnosis ''validation''. This usually includes confirmation that the patient has a diagnosis of the disease of interest, but can also involve the validation of other participant inclusion criteria. Self-rather than clinician-led validation of diagnosis can be a necessary component of patient and caregiver research, for instance where participant recruitment is not based at a clinical site. To compare the advantages and disadvantages of self-confirmed diagnosis by patients against validation by a clinician, and to explore strategies to address known issues with the former. We use our experience in developing digital studies based on patient-reported outcome measures, in tandem with published literature, to provide a comprehensive assessment of patient-led validation of diagnosis. When compared with physician-led confirmation of diagnosis, selfvalidation is inexpensive, less time-consuming, and requires no external involvement. On the other hand, fraudulent patients may enrol to the study, and genuine patients may not be able to accurately S14 Quality of Life Research (2023) 32 (Suppl 1):S1-S21 report detailed eligibility criteria, such as taking a specific treatment or their disease stage. We propose strategies to address these concerns, namely: (1) monitoring data on an ongoing basis to filter out unusual response patterns that may indicate fraudulent participation; (2) including screening questions as a part of enrolment, to which only a true patient with the disease should be able to accurately respond; (3) recruiting via patient associations or support groups, where the pool of potential participants is highly likely to be genuine; (4) requesting potential participants to scan and/or upload a diagnosis letter or medication packaging as a part of enrolment; (5) using open methods of recruitment, such as general and social media advertising, with caution. For patient-and caregiver-reported studies where data from medical records are not required, speed and convenience are often favoured. As such, self-confirmation of diagnosis is frequently accepted by stakeholders. Several strategies can be put in place to address known issues with this method of diagnosis validation, thus improving studies by maximising the amount of meaningful data collected.
A42 Using patient-reported data to estimate costs associated with melanoma in the UK: a digital registry Calculations were used to provide a snapshot of costs in the UK in 2019. Results: Taking into account several simplifying assumptions, the total costs associated with melanoma -calculated using data from 134 participants in the My Melanoma study -were estimated at £43,944 per patient, and £5.3 billion for the entire UK population. Of all domains, drug therapies were found to be the costliest, with approximately 79% of the total costs attributed to this domain alone. The costliest resource within each domain was: consultation with a medical oncologist (for routine disease management), treatment with ipilimumab (YervoyÒ) (for monotherapy drugs), and treatment with a combination of nivolumab (OpdivoÒ) and ipilimumab (YervoyÒ) (for combination therapy drugs). The cost for administration and dispensing per month of drug therapy was £232 for intravenous and £9 for oral drugs; the costs for a total of 1,390 adverse event episodes recorded in the registry were calculated at £529,105; and costs for routine disease management per month per patient were calculated at £440. Conclusions: We built a detailed, bottom-up picture of the per-patient costs to the UK health system of managing melanoma. To our knowledge, costing of the entire disease pathway in melanoma has not previously been attempted, nor costing at the level of the patient's journey. These data and results should be considered a starting point: the entire patient journey is not fully captured, and much additional specificity can be developed with more data over time.
A43 Mapping the evidence to identify outcome domains that are considered core to assessing the impact of adult specialist palliative care services in Wales Introduction: Palliative care (PC) is a relatively new, expanding field in medicine that is looking for ways to develop in order to provide the best care for patients. The assessment of PC services for the development and enhancement of care delivery is crucial. The quality and effectiveness of PC services is becoming increasingly important to measure, as PC services have previously been assessed on mostly process related outcomes. A consensus driven approach has led to the formation of some quality assessment models (such as the PCOC 1 in Australia and the OACC 2 in the UK). However, it has been identified as a priority, that there is a need for a consensus driven approach for the assessment of PC services for Wales. Objectives: To identify the most important outcomes mentioned within the literature for evaluating the quality and effectiveness of PC services and to map these outcomes into common domain themes. The mapping will be reported in the format of a rapid review, which will then feed into an expert stakeholder consensus process. Method: Five databases were systematically searched. Journal searches were also carried out to supplement the papers identified. Adapted methodology from the Palliative Care Evidence Review Service (PaCERS) 3 was used for this review. Results: Two hundred and fifty four articles were identified from the searches and nine of these met the pre-specified inclusion criteria. The most significant core outcome domains identified included: the structure and process of care, physical aspects of care and the psychological/psychiatric elements of care. Lesser mentioned domains included the social aspects and the ethical/legal elements of care. Conclusion: This review will feed into a future core outcome set consensus project and underpin the development of a future outcome measurement tool for the quality and effectiveness of PC service delivery in Wales. To achieve a truly data-driven decision making process underpinned by a value-based approach, PROMs information must be available to the right people, in the right place, at the right time. Although tools used to collect PROMs information define an agreed set of questions and possible answers, there is currently no mechanism for standardising the data captured across the range of organisations and applications that use these tools and, consequently, the data is often locked away in system and organisational silos. The standardisation model provides a basis for storing and communicating PROMs data records in a consistent way, regardless of the organisation or application. This serves as an enabler for interoperability and preservation of meaning across these boundaries, liberating the data for use in direct care, as well as in secondary uses population level analysis. The model is aligned to the principles of interoperability standards, such as HL7 FHIR and openEHR, to allow seamless and automated communication of PROMs data records. By applying these standards to a whole system architecture, the PROMs data record can be accessed wherever, and whenever, it is required. Fundamental to the model is the PROMs metadata set. Developed in collaboration with subject matter experts across NHS Wales, the PROMs metadata set is aligned to associated standards defined for clinical document repositories, meaning that completed PROMs forms can be indexed, enabling fast search and retrieval. The identifiers used anchor the patient's PROMs record to their clinical record. They provide a mechanism for linking multiple completed PROMs forms together across the longitudinal health pathway and provide the capability for linkage to other data sources, such as event-based commissioning data sets, patient-level costing and clinical outcomes, to provide a holistic value-based picture. The standardisation model incorporates a codified, digitally consumable mapping for PROMs tools. These principles allow data gathered using any nationally validated PROMs tool to be stored and communicated in an efficient and standardised format. Each question is allocated a structured identifier which is unique across all nationally validated tools and questionnaires, meaning that they can easily be identified and categorised. This is particularly beneficial for the structuring of databases and messaging schemas. The possible answers to each question are also encoded for efficiency of storage and communication, whilst also providing simple mappings for use in national analytics, enabling powerful Wales-wide data comparability. Lung cancer is responsible for a large proportion of cancer-related deaths, delayed detection is a significant factor for this high mortality rate. Radiomics is a high-throughput detection techniques of texturefeatures from medical images, has demonstrated excellent decisionmaking capacity for disease diagnosis and prognosis. Few studies have examined the radiomic signature of 18F-FDG PET/CT scan in early stage Non-Small Cell Lung Cancer (NSCLC). The present study was to retrospectively evaluate Radiomic Features (RFs) from18F-FDG PET/CT images, in a cohort of patients with early-stage NSCLC treated with radical radiotherapy to assess possible predictors and correlation with Overall Survival (OS) and clinical stage. A total of 105 patients were enrolled in the study each with histologically confirmed primary NSCLC. Tumour regions of interest (ROI) on PET images were semi-automatically segmented using region growing/ thresholding approach. Texture features were extracted using an inhouse MATLAB Programme. In total, 476 (2D&3D) RFs were extracted for each image. 167-3D features were chosen to complete the statistical analysis because the 3D analysis covers the full tumour volume and thus can better depict spatial heterogeneity. The correlation between the selected RFs and OS was examined with Spearman's Rank correlation. A univariate cox regression analysis was performed to evaluate the selected RFs in predicting the primary endpoint OS. Subsequently, significant RFs with a p-value of \ 0.05 from the univariate analysis was included in a multivariate cox regression to assess the Hazard ratio (HR) and corresponding 95% CI by considering nodal -ve patients as a control group. Multivariate cox regression analysis was fitted to the data based on clinical predictors only which are the clinical stage. Univariate analysis showed 17 RFs were significantly correlated with OS. Of these 9 features were chosen for cox regression i.e. those which had strong/very strong correlation with PET measures in spearman rank analysis (volume, GLCM-dissimilarity, GCLM-inv. Difference, GLRLM-percentage, GLSZMlzhge, GLDZM-non-uniformity, NGTD-busyness, NGTD-complexity, NGLD-non-uniformity). From the cox regression analysis, one of the RFs were significantly predictive of OS, clinical stage did however provide a good predictor for the survival rate (nodal ? ve group) (HR 3.078 P-value 0.009). An interesting finding in the analysis was the GLRLM-percentage had a HR of 6.3 which means the risk of death increased * 6 folds with this exploratory variable in the nodal ? ve group. This result was not statistically significant, future work is obtaining more patient data to re-assess these results.
A48 Evaluation of Patient and Public Involvement in the development of a patient reported outcome set in brain tumour trials (COBra Study) public involvement and signposting to other relevant PPI information was developed and tested with three Cardiff University led cancer focused studies, including one that seeks to develop a core outcome set (COS) for adult glioma patients, that takes into account patient reported outcomes (PROs). Preliminary feedback indicates that the tools are easy to understand and use. The planning tool is effective for mapping planned involvement activity and associated standards. Documenting involvement via the tracking tool is efficient when done routinely as contributions occur, and real time use was thought by researchers to make PPI feel genuinely integrated into practice instead of being bolted on. The tracking tool provides an impact focused framework that aids identification of specific public contributions that effect change. More information to help with interpretation of the standards in a study context was suggested to speed up the task of linking PPI activity to the standards. Some accessibility issues with the platform used for sharing/co-ownership of the tools were identified by public contributors. We are working towards refining the pack for a second test phase. When ready, the resource will be made widely available for use in research. Objectives: To describe development of the PaCERS methodology2, a service which is responsive to urgent, clinically driven, calls for research evidence to support service redesign opportunities or need for change to clinical care. Method: Our methodology was developed using systematic review methods to identify and appraise high quality evidence. In addition, a stakeholder workshop was held to refine our methodology and reporting processes and achieve consensus on how best PaCERS can serve the palliative care community. Results: To date we have produced eighteen evidence reviews. Findings will be presented from the point of engaging with requesters at the very start of the process to developing the review and the subsequent follow up to demonstrate impact. In addition, we will discuss the challenges involved in conducting rapid reviews and highlight methodology development unique to PaCERS. Conclusion: The principles of prudent healthcare should aim to underpin the advancement of services and close the gap between research and practice. Although, this service impact directly on palliative care clinicians and other decision makers, it effect patients/carers in receipt of palliative care. This approach could be adapted to suit partnerships between other healthcare disciplines and researchers. Background: Glucocorticoids (GCs) are a key treatment for inflammatory rheumatic diseases, but they cause a range of adverse effects of concern to patients and clinicians. Objectives: This project is to develop a Patient-Reported Outcome Measure (PROM) for glucocorticoids (the Steroid PRO). We report here our experiences of patient recruitment to an online observational survey. Methods: Underpinning qualitative interviews with 60 patients from the UK, USA and Australia have previously informed a long-list of 40 candidate questionnaire items for the Steroid PRO. These items have undergone piloting with patient partners, cognitive interviews and linguistic evaluation. This study is a large-scale online survey to test the draft Steroid PRO and determine the final scale structure and measurement properties. We collaborated with patient groups in the UK, USA and Australia who advertised the survey link with their members via email contact lists and social media platforms. The S18

A50 The development and initial impact of a cellulitis
Quality of Life Research (2023) 32 (Suppl 1):S1-S21 The mean symptom scores at baseline for this patient group were highest for pain, dyspnoea, cough, fatigue, and anorexia. This is a predictable result given these symptoms are most likely attributable to lung cancer and/or an associated comorbidity. Also as expected, the scores for nausea, vomiting, diarrhoea, constipation, and paraesthesia, were low prior to commencement of treatment. There were no significant differences in baseline symptom and QoL scores when compared on the basis of patients' age (\ 70 vs. C 70). However, in patients with higher ACE-27 scores (2-3 vs. 0-1), dyspnoea (p = 0.035), haemoptysis (p = 0.023), nausea (p = 0.041), mobility (p = 0.004) and self-care (p = 0.0420) were all significantly worse. An unexpected finding was that baseline cough (p = 0.006) and mobility (p = 0.006) were significantly worse for patients with better ECOG PS (0-1 vs. 2-3). Conclusion: Our analysis has shown that the patients who completed ePROMs were younger, fitter and healthier than the average lung cancer patient we typically see in our clinics. It has also highlighted that the Christie lung cancer-specific ePROM questionnaires appear to demonstrate adequate validity, given their findings regarding baseline symptoms and QoL scores are for the most part as expected in this patient population. University of Leeds, Leeds, United Kingdom AIM: To evaluate and compare dental anxiety in paediatric patients having dental treatment under general anaesthesia (GA) or with inhalation sedation (IHS) using psychological measure (MCDASf) before dental treatment. METHODS: The population of the study was 80 paediatric patients aged 6-15 years who were treated under GA or IHS. Faces version of the Modified Child Dental Anxiety Scale (MCDASf) was used to measure self-reported dental anxiety before dental treatment under GA or with IHS. Data was analysed using IBM SPSS Statistics 26.0 programme. RESULTS: Of 80 participants included in the study, 48 (60.0%) were female and 32 (40.0%) were male, average age of 8.44 years SD = ± 1.97. A total of 57 patients (71.3%) had their treatment under GA while 23 patients (28.7%) were treated with the help of IHS. The baseline MCDASf scores in GA group had a mean score of 21 SD = ± 6.02. The baseline MCDASf scores in IHS group had a mean score of 24 DS = ± 5.39. Anxiety score was higher in IHS patients (mean difference 2.79 (95% CI, -0.13 to 5.73) p = 0.06); however, it was not statistically significant. The most common components to rate highly in causing anxiety were 'having an injection in the gum' [n = 53, 66.3%] and 'having a tooth taken out' [n = 45, 56.3%]. These were given scores of more than 3 indicating 'a lot of worry' by 53 and 45 of the 80 patients completing the questionnaire before their treatment. CONCLUSIONS: Although MCDASf questionnaire demonstrated that children were more anxious before their treatment session with inhalation sedation when compared to general anaesthesia, it was not significant. According to the results of MCDASf questionnaire, most of the patients were highly anxious of having local anaesthesia and tooth extraction. Background: The quality of care provided for people with cognitive impairment is impacted by the research inequalities that these groups experience. People with cognitive impairment may be unable to provide informed consent and are frequently excluded from research, leading to 'evidence-biased' care. This may include people living with dementia, learning disabilities, are critically ill, or other groups unable to participate in decisions about their care. Interventions are needed to ensure these under-served groups have better opportunities to participate in research and improve future care. People with impaired capacity to consent require the involvement of alternative 'proxy' decision-makers, usually a family member. It can be challenging experience for family members, with some experiencing an emotional and decisional burden. To date, the lack of validated instruments to measure proxies' experiences of consent decisions limits our ability to evaluate interventions to support families making proxy consent decisions. This presentation outlines the development of the Combined Scale for Proxy Informed Consent Decisions (CONCORD). Methods: A four-stage process was used to develop and refine items for a new measure of proxy decision-making: 1) content generation and review of existing measures; 2) assessment of content coverage by existing measures and identification of (in)sufficiency; 3) construction of a novel scale; 4) cognitive testing to explore comprehension of the scale and test its content adequacy through interviews with family members of people with impaired capacity. Results: Core outcomes established through a recent scoping review and consensus study were reviewed to identify items for inclusion in the measurement scale. A range of outcome measurement instruments associated with healthcare decision-making and informed consent decisions were identified and mapped against the key constructs such as values clarity, understanding, preparedness, and decisional regret and satisfaction to assess content coverage. Insufficient coverage indicated that a novel measure was needed. An initial version of a combined measure (the CONCORD scale) was drafted, covering proxies' preparation for decision-making, decision-making process, and decision outcome. It was tested with eleven family members of people with impaired capacity to assess comprehension, acceptability, feasibility, and content adequacy, leading to the creation of a revised version. Conclusions: CONCORD provides a measure of families' experience of decision-making on behalf of an adult who lacks capacity, enabling the evaluation of interventions to support proxy decisions and improve inclusion of this under-served group in research. Initial evaluation indicates content adequacy, acceptability, and feasibility. Further work to concurrently validate the scale is underway. Forensic mental health services provide care to people with severe mental illness who also pose a risk to others, in secure psychiatric hospitals and specialised community teams. Measuring outcomes of forensic mental health services is important to safeguard patients and the public, monitor progress and develop treatment plans. Little is known about which outcomes are most important and existing measures have had limited patient input into their design, demonstrate variable psychometric properties, and are often not well liked by clinicians. A project to develop a new outcome measure was codesigned with patients, carers and the public. A dedicated patient and public advisory group was established to guide the work throughout its lifecycle and contributed to project methodology, data interpretation and dissemination of results. Patients, carers and professionals from forensic mental health services were interviewed and took part in focus groups to identify which outcomes were important to them. Forty-two outcomes were identified in the six domains of 'about me, my quality of life, my health, my safety and risk, my life skills and my pathway'. These outcomes were then prioritised by asking patients, carers and professionals to rate their importance through a Delphi process. Eight of the top fifteen outcomes were shared between patients/carers and professionals. A new instrument for measuring outcomes in forensic mental health services was then developed, called the FORensic oUtcome Measure (FORUM), with complementary patient (FORUM-P) and clinician (FORUM-C) reported questionnaires. Patients and their clinical teams at a regional forensic psychiatric service then completed the FORUM. Patients and clinicians also provided feedback on the questionnaires. Sixty-two patients participated with a mean age of 41.0 years (standard deviation 11.3) and 35 clinicians completed the FORUM-C. Cronbach's alpha for the FORUM-P was 0.87 (95% confidence interval (CI) 0.80-0.93) and the FORUM-C was 0.93 (95% CI 0.91-0.96). The weighted kappa for test-retest reliability for the FORUM-P was 0.44 (95% CI 0.24-0.63) and for the FORUM-C was 0.78 (95% CI 0.73-0.85). For interrater reliability of the FORUM-C the Spearman correlation coefficient was 0.47 (95% CI 0.18-0.69). The FORUM-P received an average rating of 4.0 out of 5 for comprehensiveness, 4.6 for ease of use and 3.9 for relevance, while the FORUM-C received 4.1 for comprehensiveness, 4.5 for ease of use and 4.3 for relevance. These results indicate that the FORUM is a promising new instrument to measure outcomes in forensic mental health services.
Data availability Data sharing not applicable to this article as no datasets were generated or analysed during the current study.

Declaration
Ethics statement The conference was sponsored by WViHC and Oxford.
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